Non-Inferiority Trials Quiz

To demonstrate that the new intervention is not worse than the standard by a predefined margin

To test whether a new intervention is equivalent to an established one

It must be one that the new intervention is not worse than by a predefined margin

Less toxic, less invasive, less costly, require fewer doses

Studies of equivalency test whether a new intervention is equivalent to an established one, while studies of non-inferiority test whether the new intervention is no worse than an established one

The primary goal of a non-inferiority trial is to demonstrate that the new intervention is not worse than the standard by a predefined margin. This differs from a superiority trial, which aims to show that the new intervention is better than the control, without specifying a margin of non-inferiority.

A new intervention may be of interest in non-inferiority trials because it is less toxic, less invasive, less costly, requires fewer doses, improves quality of life, or provides other value to patients, even if it does not demonstrate superiority over existing therapies.

The key objective of studies of equivalency is to test whether a new intervention is equivalent to an established one, while the objective of studies of non-inferiority is to test whether the new intervention is no worse than, or at least as good as, some established intervention.

The active control selected in non-inferiority trials must be one that is a well-established treatment for the condition being studied and has been shown to be effective in previous trials.

Demonstrating non-inferiority in a clinical trial is significant because it provides evidence that the new intervention is at least as good as the standard treatment, which can be valuable in cases where the new intervention offers other benefits such as reduced toxicity, invasiveness, or cost.